MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO; SURGICAL MESH

Catalog Number	5955610
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, patient underwent incisional hernia repair surgery with implant of ventralight st w/echo using sorbafix enhanced fixation device on (b)(6) 2020.As reported post procedure patient is experiencing chronic pain.
Additional Manufacturer Narrative
As reported, patient has experienced chronic pain post implant of ventralight st w/echo using sorbafix enhanced fixation device.Based on the event as reported the degree to which the mesh implant used to treat the patient may have caused or contributed to the patient¿s post operative course cannot be determined.The adverse reaction section of the instructions-for-use supplied with the device lists pain as a possible complication.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Note, the date of event (27-may-2025) is considered to be a best estimate based on the date of awareness.This mdr represents the ventralight st w/echo (device #1).An additional mdr was submitted to represent the sorbafix enhanced (device #2).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 22293135
• Report Number: 1213643-2025-00504
• Device Sequence Number: 8929843
• Product Code: FTL
• UDI-Device Identifier: 00801741031748
• UDI-Public: (01)00801741031748(17)210528(10)HUDR1669
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: 5955610
• Device Lot Number: HUDR1669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female